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Allergen EU declaration sulphites

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catherinepc

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Posted 25 February 2019 - 06:27 AM

Hi all !

 

I would like to check on declaration of Allergen. Our company is doing liquid food flavouring.

Recently I have one new raw material which contains >10ppm sulphites (EU regulated allergen) according to supplier's product spec.

I send out some sample to an external lab to check on sulphites and the result is less than 10ppm.

 

My question is do we still need to declare the sulphites as allergen when the test result is <10ppm in our finished product?

 

Thank you. 



Charles.C

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Posted 25 February 2019 - 07:21 AM

Hi all !

 

I would like to check on declaration of Allergen. Our company is doing liquid food flavouring.

Recently I have one new raw material which contains >10ppm sulphites (EU regulated allergen) according to supplier's product spec.

I send out some sample to an external lab to check on sulphites and the result is less than 10ppm.

 

My question is do we still need to declare the sulphites as allergen when the test result is <10ppm in our finished product?

 

Thank you. 

 

9.9 ppm ?

 

One sample ?

 

Methodology ?

 

How much do you like gambling ? :smile:


Kind Regards,

 

Charles.C


lurah11

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Posted 25 February 2019 - 09:40 AM

Hi catherinepc

 

As i remember, when the sulfite concentration is below 10 ppm in your final products, you dont need to declare the allergen warning.  For validation stages, i think you should send more samples, so you can ensure statistically that your products will contain < 10 ppm with certain confidence levels( 95 % , for example ). You can try capability analysis for this one, but make sure you do representative sampling. For sampling plan, you can try acceptance sampling plan by considering batch size, AQL, RQL, producer risk and consumer risk. 

 

After you make this validation documents, do not forget to consult with your authorized food safety regulatory  body to ensure the compliance. 

 

Or if this explanation rather confusing for you, you can ask the validation method to your authorized food safety regulatory body directly and do as they say to you :D



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pHruit

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Posted 25 February 2019 - 12:23 PM

Hi catherinepc

 

As i remember, when the sulfite concentration is below 10 ppm in your final products, you dont need to declare the allergen warning. 

For the EU market, the specific requirement is relating to products that contain >10mg/kg or 10mg/L "which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers" - for a flavouring product it is therefore possible that it may contain >10mg/kg as manufactured, but wouldn't be directly consumed in this form and could thus be below the 10mg/kg threshold in accordance with the labelling requirement.

 

Nonetheless, as both Chares and lurah11 have advised, I'd be looking at the analytical detail and particularly checking to see whether it was free or total sulphites that was measured (as the regs refer to the latter).

Before getting too bogged down in the subtleties of the labelling I'd also be speaking to the supplier as a priority - if SO2 is supposed to be in the product but isn't then there is perhaps a danger that you're going to make a key labelling decision based on a sample/batch that was out of spec?



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Charles.C

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Posted 25 February 2019 - 09:40 PM

Hi Catherine,

 

Just as an extension of the previous Post, how much sulphite was the item supposed to contain ? (>10ppm is not a very satisfactory "specification").


Kind Regards,

 

Charles.C


catherinepc

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Posted 26 February 2019 - 02:40 AM

Hi Catherine,

 

Just as an extension of the previous Post, how much sulphite was the item supposed to contain ? (>10ppm is not a very satisfactory "specification").

Hi Charles,

 

As what stated on the supplier product spec is "Sulphites 1,000ppm". 

In our formulation, the maximum dosage of caramel that we use is about 10% in 100. 



catherinepc

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Posted 26 February 2019 - 02:53 AM

Hi catherinepc

 

As i remember, when the sulfite concentration is below 10 ppm in your final products, you dont need to declare the allergen warning.  For validation stages, i think you should send more samples, so you can ensure statistically that your products will contain < 10 ppm with certain confidence levels( 95 % , for example ). You can try capability analysis for this one, but make sure you do representative sampling. For sampling plan, you can try acceptance sampling plan by considering batch size, AQL, RQL, producer risk and consumer risk. 

 

After you make this validation documents, do not forget to consult with your authorized food safety regulatory  body to ensure the compliance. 

 

Or if this explanation rather confusing for you, you can ask the validation method to your authorized food safety regulatory body directly and do as they say to you :D

Hi Lurah11,

 

We can send a few samples for validation purpose. However the percentage of the caramel that we use in our formulation more or less will be the same. The max is about 10% of 100. 

 

In our country regulation, sulphites is not listed as a food allergen. But because most of our customer comply to EU regulation, that is why we need to look into this.  :uhm:



lurah11

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Posted 26 February 2019 - 08:43 AM

Hi catherinepc

 

Oh , seems like i know this caramel, caramel class IV?  :D

 

 

This is additional information  : 

1. In Final products --> You need to consider batch size, if you produce many products in 1 batch, you need to do more sampling, you can refer to ISO 2859-1 for optimum sampling size for certain batch size.  Do this once for validation,,, but don't forget to re-validate if there are any changes in your production process or formulas.  

 

2. Other possible cross contaminated area --> You need to do this if you also produce other products that do not contain sulfites. You can try allergen swab in those potential cross contamination area ( mixing tank for example ). The purpose of this validation is to ensure that your cleaning procedure is effective. 

 

3. Allergen management programs --> No 1 and no 2 are part of  allergen management programs, you also need to consider other area such as segregation in warehouse, production schedule arrangement and so on. 

 

I think it should be OK as long as your allergen management program is effective :D



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Charles.C

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Posted 26 February 2019 - 09:25 AM

Hi Charles,

 

As what stated on the supplier product spec is "Sulphites 1,000ppm". 

In our formulation, the maximum dosage of caramel that we use is about 10% in 100

 

Hi Catherine,

 

Sorry I have no idea what that ^^^ means. 100 what ?

 

My guess is that 1000ppm is a ballpark figure unless calculated from the ingredient formula.

 

Presumably you can calculate the likely level if original value is "reliable".

 

 

see posts 2,3.


Kind Regards,

 

Charles.C


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catherinepc

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Posted 01 March 2019 - 03:14 AM

Hi catherinepc

 

Oh , seems like i know this caramel, caramel class IV?  :D

 

 

This is additional information  : 

1. In Final products --> You need to consider batch size, if you produce many products in 1 batch, you need to do more sampling, you can refer to ISO 2859-1 for optimum sampling size for certain batch size.  Do this once for validation,,, but don't forget to re-validate if there are any changes in your production process or formulas.  

 

2. Other possible cross contaminated area --> You need to do this if you also produce other products that do not contain sulfites. You can try allergen swab in those potential cross contamination area ( mixing tank for example ). The purpose of this validation is to ensure that your cleaning procedure is effective. 

 

3. Allergen management programs --> No 1 and no 2 are part of  allergen management programs, you also need to consider other area such as segregation in warehouse, production schedule arrangement and so on. 

 

I think it should be OK as long as your allergen management program is effective :D

Yup, you are correct ! That's the caramel that we are going to use. 

Thank you for your suggestion. Appreciate it so much. 







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